26
Participants
Start Date
September 24, 2012
Primary Completion Date
September 26, 2019
Study Completion Date
February 3, 2020
Vincristine
Vincristine (VCR) = 1.5 mg/m\^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes
Irinotecan
Irinotecan (IRN) = 50 mg/m\^2/day, days 1-5, IV over 60 minutes
Temozolomide
Temozolomide (TEM) = 50 mg/m\^2/day by mouth (PO) Days 1-5
Metformin
Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.
The Children's Hospital at Montefiore, The Bronx
Nemours/Alfred I. duPont Hospital for Children, Delaware, Wilmington
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore
University of North Carolina at Chapel Hill, Chapel Hill
Nemours Children's Clinic, Jacksonville
University of Florida, Gainesville
University of Miami Sylvester Comprehensive Cancer Center, Miami
Tampa General Hospital, Tampa
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Johns Hopkins All Children's Hospital, St. Petersburg
University of Kentucky, Lexington
Nationwide Children's Hospital, Columbus
Primary Children's Medical Center/Utah, Salt Lake City
Connecticut Children's Medical Center, Hartford
Pediatric Cancer Foundation
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER